Prius Medical Systems LLC

Website Links

Description

Prius Medical Systems is always ahead of the curve when it comes to medical systems program delivery. As a forward thinking consultancy with extensive expertise in the medical device, biologics, and pharma space that is both broad and deep, we combine our expertise with the cost advantages and scalability of offshoring strategically applied to complement and augment your capabilities in information technology, new product development, manufacturing, lab automation, clinical trials management, regulatory compliance, quality systems, and continuous process improvement. Our team consists of former senior managers and practitioners coming from large medical devices and pharma companies like Abbott, Baxter, Siemens, Philips, Marconi, etc. with extensive operational, product development, and process compliance expertise in the context of multinational operations and offshoring. Most of us have been trained by the people who train the FDA auditors, and we all have a meaningful track record of successfully interfacing with the Agency in all types of situations starting with on-site audits, implementing remedial action in response to 483s and warning letters, and all the way up to operating under consent decree. Additionally, most of our senior partners have a strong business background in this space, having participated in strategic planning, technology roadmapping, business development, mergers & acquisitions, due diligence activities, and post-merger integration efforts. Dan M. Mihai - Managing Consultant As a medical industry expert with more than 25 years of experience, Mr. Mihai has held senior management positions in companies like Philips, Baxter, Siemens, Marconi, and GN Otometrics and is currently assisting companies in this space optimize their drug and device development initiatives with an emphasis on technology implementation, program delivery, process improvement, verification & validation, and regulatory compliance from an operational standpoint. Dan has 12 patents in the medical field, holds both MS-EE and MBA degrees, and has completed the Executive Development Program at the University of Chicago Booth School of Business.

Products & services

Similar companies nearby